News and Articles
FDA Draft Guidance for Misinformation – Part 2
In a previous post, we discussed the FDA’s July 2024 Draft Guidance entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (the “Draft Guidance”). The Draft Guidance suggests a purportedly voluntary pathway for drug and device sponsors, manufacturers, distributors, and other stakeholders legally responsible for the labeling of approved/cleared medical products (“firms”)…
Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain
Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three…
The Growth of Digital Health – Exploring the Driving Forces Behind its Expansion
Digital health technology is experiencing a period of unprecedented growth and innovation. The global digital health market is projected to expand from $309B in 2023 to $1,019B by 2032 with a Compound Annual Growth Rate (CAGR) of 12%. Europe is reportedly the largest market, while Asia Pacific is the fastest-growing region. Although many factors contribute…
The Evolution of Benzene Litigation & Considerations for Product Manufacturers
Benzene may not be a household name, but in the last few years, this chemical compound has garnered public attention for its presence in everyday products and its potential cancer risks. Since discovered over two centuries ago, benzene has been used to manufacture plastics, dyes, adhesives, gasoline, cleaning products, and personal care products. With the…
FDA’s New Draft Guidance for Internet Misinformation about Medical Products
You may remember the internet postings during the height of the COVID pandemic touting hydroxychloroquine, a drug approved by the Food and Drug Administration (FDA) for the treatment of malaria and rheumatologic disease, as a prophylactic or even a cure-all for COVID-19. The postings, many initiated by celebrities such as Elon Musk and Dr. Oz…
Applying Occupational Exposure Banding to Antibody Drug Conjugates
Occupational Exposure Banding (OEB), also known as hazard banding, is a process used for assigning chemicals into categories based on toxicological potency and potential health hazard. OEB has been used to help organizations define and identify worker health exposures since the mid-1990s and has primarily focused on small-molecule chemicals, which make up most market pharmaceuticals….
Considerations for Conducting International Clinical Trials
As a startup life science company, you are excited by the promising laboratory results for your novel drug, but you must first test the product’s safety and efficacy through clinical trials. To expedite the process, you work with a clinical research organization to conduct trials outside the United States. All goes well until a clinical…
An Introduction to Innovator Liability: Brand-Name Responsibility for Generic Drug Failure to Warn Injuries
Innovator liability is a legal theory under which a consumer seeks to hold the brand-name manufacturer of a drug (the “innovator”) responsible for an injury that was caused by the generic version of that drug. This novel approach to injury culpability has gained modest ground in recent years, despite its departure from long-standing product liability…
Melatonin: The Benefits vs. the Risks of the Dietary Supplement
Melatonin was first identified by Aaron B. Lerner, an American physician and dermatologist at Yale University, in 1958. Dr. Lerner and his colleagues were initially investigating a cure for vitiligo, an autoimmune disorder characterized by the loss of skin pigmentation. Although the experimentation failed to find a cure for skin disorders, subsequent research revealed that…
The Risks of Employees Driving in Foreign Territories
The hazards of driving increase when you or your employees drive in unfamiliar territory. This is especially true when driving in foreign territories without knowing the driving rules and habits within the country. Being unfamiliar with local regulations, failing to adhere to them, or making incorrect assumptions increases the likelihood of accidents. Factors That Increase…
